Prospective, multicenter study on the economic and clinical impact of gene-expression assays in early-stage breast cancer from a single region:: the PREGECAM registry experience

• S. Pérez Ramírez ^[1] ; M. del Monte-Millán ^[1] ; S. López-Tarruella ^[1] ; N. Martínez Jáñez ^[2] ; I. Márquez-Rodas ^[1] ; F. Lobo Samper ^[3] ; Y. Izarzugaza Perón ^[3] ; C. Rubio Terres ^[14] ; D. Rubio Rodríguez ^[14] ; J. Á. García-Sáenz ^[4] ; F. Moreno Antón ^[4] ; P. Zamora Auñón ^[5] ; M. Arroyo Yustos ^[6] ; M. Á. Lara Álvarez ^[7] ; E. M. Ciruelos Gil ^[8] ; L. Manso Sánchez ^[8] ; M. J. Echarri González ^[9] ; J. A. Guerra Martínez ^[10] ; C. Jara Sánchez ^[11] ; C. Bueno Muiño ^[12] ; S. García Adrián ^[13] ; J. R. Carrión Galindo ^[15] ; V. Valentín Maganto ^[16]
  1. [1] Hospital General Universitario Gregorio Marañón

     Hospital General Universitario Gregorio Marañón

     Madrid, España

     
  2. [2] Hospital Ramón y Cajal

     Hospital Ramón y Cajal

     Madrid, España

     
  3. [3] Fundación Jiménez Díaz

     Fundación Jiménez Díaz

     Madrid, España

     
  4. [4] Instituto de Investigación Sanitaria del Hospital Clínico San Carlos

     Instituto de Investigación Sanitaria del Hospital Clínico San Carlos

     Madrid, España

     
  5. [5] Hospital Universitario La Paz

     Hospital Universitario La Paz

     Madrid, España

     
  6. [6] Hospital Universitario Príncipe de Asturias

     Hospital Universitario Príncipe de Asturias

     Alcalá de Henares, España

     
  7. [7] Hospital Infanta Leonor

     Hospital Infanta Leonor

     Madrid, España

     
  8. [8] Hospital Universitario 12 de Octubre

     Hospital Universitario 12 de Octubre

     Madrid, España

     
  9. [9] Hospital Severo Ochoa

     Hospital Severo Ochoa

     Madrid, España

     
  10. [10] Hospital de Fuenlabrada

      Hospital de Fuenlabrada

      Fuenlabrada, España

      
  11. [11] Fundación Hospital Alcorcón

      Fundación Hospital Alcorcón

      Alcorcón, España

      
  12. [12] Hospital Infanta Cristina

      Hospital Infanta Cristina

      Parla, España

      
  13. [13] Hospital de Móstoles

      Hospital de Móstoles

      Móstoles, España

      
  14. [14] HEALTH VALUE, Health Economics & Research of Outcomes Consulting, Madrid, Spain
  15. [15] Medical Oncology Service, Hospital del Sureste Arganda del Rey, Madrid, Spain
  16. [16] Regional Oncology Coordinator, Madrid, Spain

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• Localización: Clinical & translational oncology, ISSN 1699-048X, Vol. 22, Nº. 5, 2020, págs. 717-724
• Idioma: inglés
• Texto completo no disponible (Saber más ...)
• Resumen

  • Introduction The aim of this study is to evaluate the cost-effectiveness and impact of gene-expression assays (GEAs) on treatment decisions in a real-world setting of early-stage breast cancer (ESBC) patients.

    Methods This is a regional, prospective study promoted by the Council Health Authorities in Madrid. Enrolment was offered to women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, node-negative or micrometastatic, stage I or II breast cancer from 21 hospitals in Madrid. Treatment recommendations were recorded before and after knowledge of tests results. An economic model compared the cost-effectiveness of treatment, guided by GEAs or by common prognostic factors.

    Results 907 tests (440 Oncotype DX® and 467 MammaPrint®) were performed between February 2012 and November 2014. Treatment recommendation changed in 42.6% of patients. The shift was predominantly from chemohormonal (CHT) to hormonal therapy (HT) alone, in 30.5% of patients. GEAs increased patients’ confidence in treatment decision making. Tumor grade, progesterone receptor positivity and Ki67 expression were associated with the likelihood of change from CHT to HT (P < 0.001) and from HT to CHT (P < 0.001). Compared with current clinical practice genomic testing increased quality-adjusted life years by 0.00787 per patient and was cost-saving from a national health care system (by 13.867€ per patient) and from a societal perspective (by 32.678€ per patient).

    Conclusion Using GEAs to guide adjuvant therapy in ESBC is cost-effective in Spain and has a significant impact on treatment decisions.